Egas Moniz School of Health and Science
Almada, Monte Da Caparica, 2829-511, Portugal
Location status: Recruiting
NCT Number: NCT07191522
Peri-implantitis is a growing public health problem that can lead to several complications and sequelae, with a serious impact on the health and quality of life of patients and a high cost for healthcare systems.
Bacterial plaque that accumulates around dental implants leads to peri-implant tissue inflammation that ultimately can result in the loss of the implant, significant bone destruction and infection that can reach other regions. Successful implant decontamination is necessary to preserve the implant and several strategies have been suggested for this purpose, however, there is still no fully effective treatment modality and failures and recurrence are relatively frequent.
To better understand this problem and develop more effective treatment strategies, investigators will first conduct an epidemiological study to understand the factors associated with the development of this pathology. Although there is data at an international level, the incidence of this problem in Portugal has not yet been properly studied. Later investigators will conduct a randomized clinical trial to evaluate the 6-week clinical outcomes of patients treated with a photodynamic therapy as an adjuvant versus the use of conventional titanium implant curettes for implant surface decontamination in the non-surgical treatment. Sixty patients/implants with peri-implantitis and within the established criteria, will undergo non-surgical treatment with one of the two protocols being studied. Various clinical and radiographic parameters will be evaluated, such as probing depth, insertion loss, recession, bleeding on probing, suppuration, peri-implant crevicular fluid volume, alveolar bone loss and peri-implantitis microbiome will be evaluated before surgery and 6 weeks after surgery.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Removal of deposits above and below the gum line using hand or ultrasonic tools to reduce the inflammatory parameters
Non-invasive treatment that uses a combination of a light-sensitive compound (photosensitizer), specific light and oxygen to generate reactive oxygen species (ROS) that kill bacteria
Time frame: From enrollment to the end of treatment at 3 months
Measuring in milimeters the distance from the gingival margin to the base of a sulcus or peri-implant pocket, using a periodontal probe.
Time frame: From enrollment to the end of treatment at 3 months.
Measured with a periodontal probe as the distance from a fixed reference point (usually the implant shoulder or gingival margin) to the base of the peri-implant pocket.
Time frame: From enrollment to the end of treatment at 3 months.
Assessed during gentle probing; bleeding indicates a positive site.
Time frame: From enrollment to the end of treatment at 3 months.
Detected by probing or gentle pressure, with purulent exudate confirming presence.
Time frame: From enrollment to the end of treatment at 3 months.
Assessed on standardized periapical radiographs, measuring the distance from a fixed reference point (implant shoulder or platform) to the most coronal bone-to-implant contact.
Time frame: From enrollment to the end of treatment at 3 months.
Changes in the microbiome collected from peri-implant pockets sequencing 16S ribosomal RNA gene
Contact information is provided by the study sponsor or research team.
Inês Gomes, PhD
CONTACT
212946748 ext. 00351
Mariana A Assunção, Master
CONTACT
+351919970304 ext. 00351
Egas Moniz - Cooperativa de Ensino Superior, CRL
Other
Acronym: PeriimpMAA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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